Neoadjuvant Immunoradiotherapy: Head & Neck Cancer (NIRT-HNC)
The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical resection.
• Patients with squamous cell carcinoma of the head and neck region, (including mucosal,cutaneous, or nodal) who are planned for surgical resection and in the opinion of the investigator are able to safely undergo neoadjuvant anti-PD-1 and radiation. In addition, the following are eligible (but will not contribute toward total accrual): non-surgical cases that are planned for palliative RT or that refuse or are unfit for definitive concurrent chemotherapy.
• HPV status as determined by p16 immunostain
• Cohort 3: HPV-positive patients only
• Cohort 4: HPV-negative patients only
• Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document. Patients with history of psychiatric illness must be judged by the investigator as able to understand the investigational nature and risks associated with the therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status deemed suitable by investigator for study requirements.
• Laboratory values (most recent), must be within 6 weeks of week 0 on study:
‣ WBC ≥ 2000/uL, ANC ≥ 1000/uL
⁃ Hgb \> 8g/dL (patients may be transfused to reach this level)
⁃ Platelets \> 50,000 cells/mm3
⁃ Creatinine ≤ 3 x ULN
⁃ AST/ALT ≤ 5 x ULN for subjects without liver metastasis; or ≤ 8 x ULN for subjects with liver metastasis, \[per investigator brochure\]
⁃ Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
⁃ Negative pregnancy test (bHCG urine or serum, women of childbearing potential only)
• Women of child-bearing potential (WOCBP) must agree to follow adequate contraceptive practices to avoid pregnancy for the duration of treatment with nivolumab plus 5 half-lives of nivolumab (75 days) plus 30 days (duration of ovulatory cycle) for a total of 105 days post-treatment completion.
• Males who are sexually active with WOCBP must agree to follow adequate contraceptive practices to avoid pregnancy for the duration of treatment with study drug (s) plus 5 half lives of the study drug (75 days) plus 90 days (duration of sperm turnover) for a total of 165 days post-treatment completion.